Drape



Nov. 29, 1966 Filed Nov. 22. 1965 L. PERENY ET AL DRAPE 2 Sheets-Sheet lINVENTORS PAUL CREAGER, JFL, THOMAS N. ZINCK LOUIS PERENY, DECEASED, BYEVELYN PERENY, EXECUTRIX ATTORNEYS L. PERENY ETAL DRAPE Filed NOV. 22,1963 I/ 2 T 34-64 1 A /z /////;V 1 ,4 v g/ q 2 Sheets-Sheet 2 INVENTORSPAUL CREAGER, JR, THOMAS N. ZINCK,

LOUIS PERENY, DECEASED,

EVELYN PERENY EXECUTR IX United States Patent 0 M 3,288,135 DRAPE LouisPereny, deceased, late of Dayton, Ohio, by Evelyn Pereny, executrix,Dayton, Ohio, and Paul Creager, Jr., and Thomas N. Zinck, Dayton, Ohio,assignors to Protective Treatments, Inc., Dayton, Ohio, a corporation ofOhio Filed Nov. 22, 1963, Ser. No. 325,733 9 Claims. (Cl. 128132) Thepresent invention relates to a bifurcated plastic surgical drape whichis adhesively secured below the vaginal area to aseptically wall oifthis area from the anal area and which is especially adapted to toleratethe extensive streaching of the vaginal area which takes place during anobstetrical delivery.

During any surgical operation conducted in the vaginal area, andespecially during delivery, contamination of the surgeons hands from theanal area, including any fecal extrusion which may occur during theoperation, is a serious problem. The danger of such contamination issignificantly reduced by the use of the surgical drape of the invention.

The adhesive application of plastic drapes over a surgical area toprevent contamination of the operative site is now known and is wellillustrated in Pereny et al. Patent 3,060,932. However, when theoperation performed in the vaginal area is an obstetrical delivery, aplastic drape adhesively secured around the'vaginal area does notadequately tolerate the extensive expansion in the vaginal area whichoccurs during delivery and the drape may tear or become separated fromthe skin to destroy asepsis.

According to the invention, the hazard of contamination from the analarea is effectively eliminated despite extensive expansion in thevaginal area by aseptically walling off the anal area from the vaginalarea with a bifurcted plastic drape adhesively secured to the patientand which extends across the space between the vaginal and anal areas.The bifurcated configuration of the drape tolerates the extensiveexpansion in the vaginal area which occurs during delivery withoutdestroying asepsis.

The surgical drape of the present invention comprises a s'heetofflexible plastic material, preferably a clear vinyl film, having acentral arcuate cut-out portion in one end thereof defining a pair ofupper end portions (the bifurcation) adapted to be adhesively secured tothe thighs of the patient adjacent to the buttocks, the arcuate bottomof the cut-out portion being adapted to be adhesively secured across thespace between the vaginal area and the anal area. When the thighs arereferred to, it should be understood that the upper end portions mayalso, in part, be secured to part of the perineal area and, indeed, offcenter application of the drape is also contemplated.

The curved configuration of the cut-out portion in combination with theupper end portions is especially designed to tolerate the extensiveexpansion in the vaginal area during delivery without tearing the drapeand without imposing nonuniform stresses on the edges of the cutoutportion of the drape which causes the drape tobe separated from theskin. As will be evident, the tearing and separation referred to areundesirable since either of them will destroy asepsis.

The cut-out portion of the drape is defined by a curved bottom smoothlyjoined with two side portions which flare outwardly from the cut-outportion to the upper edge of the drape. The curved configuration of thebottom of the cut-out permits the drape to tolerate expansion in thevaginal area and to uniformly distribute the stresses imposed by suchexpansion so that the expansion will be ing surface of the paper liner.

3,288,135 Patented Nov. 29, 1966 tolerated without destroying asepsis aswill appear more fully hereinafter.

A further feature of the present invention is the utilization of arelatively stiff paper liner of approximately the same size and shape asthe drape which facilitates the handling and application of the drapewhich, without the liner, is difficult to handle and apply due to theflexible and limp nature of the plastic material. To facilitateconvenient and accurate application of the drape, it is desirable thatthe drape be combined with the liner to facilitate application of thedrape to the patient with one hand while the other hand holds the drape,the paper liner, or the combination of drape and paper liner.

The invention will be more fully understood in connection with theaccompanying drawings in which:

FIG. 1 is a plan view showing the configurated drape of the inventionhaving a paper liner positioned thereon;

FIG. 2 shows the combination of FIG. 1 in a folded position;

FIG. 3 shows the bottom of a drape provided with a preferred portion ofits s ur-face coated with an adhesive;

FIG. 4 shows the preferred dimensions of the cut-out portion of thedrape;

FIG. 5 shows the manual application of the drape to a patient; and

FIG. 6 shows the drape in position on a patient.

Referring more particularly to FIG. 1 which shows a preferredconstruction, the drape 10 is rectangular, preferably square, and formedfrom a single sheet of limp and flexible polyvinyl chloride plasticmaterial. Cut-out portion 11 is formed in the upper end of the drape 10and is defined by the flared out sides 12 joined at the bottom by acurved or arcuate bottom 13 which merges with the flared out sides 12tangentially. The sides 12 of the cut-out portion 11 define the inneredge of two upper end portions 14 which, together, form the bifurcatedupper end which is adapted for adhesive securement to the patient.

Overlying the configurated plastic drape is a stiff paper liner 15 whichis preferably of exactly the same size and shape as the drape but, forclarity of representation, is shown in a less preferred form in whichthe liner is of slightly smaller size. This paper liner facilitateshandling of the drape as has been noted.

As a feature of the invention, the stiff paper liner 15 is temporarilyand removably adhesively secured to the upper surface of the drape 10,at least over the upper portion thereof. This temporary securement iseasily achieved by a thin coating of wax applied to the contact- The waxcoated paper liner is then lightly heat-sealed to the drape. Thistemporary securement is not shown in the drawing because of thedifficulty of illustration.

The drape and the paper liner are preferably folded in a particularmanner to facilitate application of the drape to the patient. As can beseen in FIGURES 1 and 2, the drape and liner are folded along the line16 which parallels the upper end of the drape and extends across thedrape a short distance beneath the bottom 13 of the cut-out 11 so thatthe paper liner is between the plastic drape in the folded state as canbe seen in FIG- URE 2. This folded structure is highly useful in theapplication of the drape to the patient as will appear more fullyhereinafter. The drape may, optionally, be folded vertically along line17 for packaging purposes.

Various techniques, not shown, may be used to facilitate separation ofthe paper liner after the drape has been adhesively secured to thepatient including tabs, upward folding of the lower end of the drape 10beneath the downwardly folded upper end of the drape 10 shown in FIG. 2,inwardly folded corners, etc.

The drape of the invention is adhesively secured to the patient with apressure sensitive adhesive which holds the drape securely in place.Adhesive specially adapted for application to the patient are shown inUnited States Patent 3,090,694.

An adhesive may be applied to the bottom or patient contacting surfaceof the drape during its manufacture or just prior to its use, thoughthese applications are less preferred. Appropriate areas for adhesiveapplication are shown in FIGURE 3 and identified by numeral 18. When theadhesive is applied to the drape during manufacture, and as is wellknown, the adhesive is a pressure sensitive adhesive and is protected bya relatively nonadherent paper liner which is removed during applicationor just prior to application. This non-adherent paper liner may becoextensive with the drape and serve in place of the paper line referredto hereinbefore in which event, it would be applied to the bottom orpatient contacting surface of the drape instead of the top surface ofthe drape.

When the adhesive is applied directly to the patient, it is desirablysprayed onto the region where the thighs join the buttocks and acrossthe space between the vaginal and anal areas. The adhesive is applieduniformly so that the upper portion of the drape is uniformly adhered tothe patient in the areas which have been noted. These areas are picturedin FIGURE 5 and identified by numeral 21. Application of the adhesive tothe patient avoid-s any problem of inadvertent adhesion prior toapplication.

The adhesive is desirably applied as an aerosol spray since sprayapplication is quite convenient as is disclosed in United States Patent3,090,694. When using spray application, the vagina is preferably sealedoff by the insertion therein of a surgical sponge or like material.

The application of the drape is preferably accomplished using the foldedstructure previously noted to assist guiding the drape to its properlocation with one hand. This is shown in FIGURE 5, the forefinger 19 ofthe hand 20 being placed at the center of the drape at the fold line 16to facilitate accurate placing of the drape. The thumb and the otherfingers remain beneath the fold to support the drape and the other handmay be use-d, as shown, to hold and position the combination of drapeand liner.

The applicator directs his forefinger to a point beneath the vagina andpresses the drape to adhesively secure it at this point. The hands arethen moved upwardly to smoothly adhere the end portions 14 on the thighsadjacent the buttocks. The areas covered by adhesive on the patient areshown by shading and identified by numeral 21 in FIGS. 5 and 6.

The paper liner assists in this operation by making the plastic drapestiff enough for easy handling. It can be readily understood that thepaper liner is preferably not larger than the drape itself as the linerwould then adhere to the adhesive on the patient. The paper liner ispulled away from the drape and discarded once the drape is adhered inits desired position.

FIG. 6 shows the drape in position on the patient. As is shown by theshaded portion 22, the adhesive secures the upper bifurcated portion ofthe drape completely to the patients thighs, buttocks and perineal areato thereby aseptically wall off the anal area.

The cut-out portion 11 of the drape 10 is shaped, as previouslyindicated, to include outwardly tapering side margins 12 and an arcuateor curved bottom 13 which merges therewith. Of particular importance tooptimum performance is the curvature at the bottom 13 which can varyfrom a curve corresponding to a circle having a radius from /2 inch to 1inch, but which is preferably about inch. While circles are referred to,it isnot essential that the curve used correspond precisely with the arcof a circle, though this is preferred. The outwardly flaring sidemargins 12 are also desirably curved so that the entire cut-out portion11 resembles one-third of an ellipse severed across its shorterdiameter. The depth of the cutout portion 11 is roughly the same as itswidth where it joins the upper margin of the drape 10. While overalldimensions are not of prime significance, these dimensions of depth andwidth of the cut-out 11 may vary between 1 /2 inch to'4 inches, theparticular dimensions preferred being based upon the size and shape ofthe average patient. A preferred cut-out depth is 2% inches and apreferred width at the top of the cut-out is 3% inches. The preferablycurved side margins 12 of. the cut-out 11 are preferably curved tocorrespond with a circle having a radius of 3% inches with its center atthe opposite juncture of the cut-out portion and the upper margin of thedrape. Preferred dimensions for the cut-out portion are shown in FIGURE4.

While it is preferred to utilize a rectangular drape, variations of thelower portion of the drape may be made without changing the utility ofthe drape such as a rounded drape, triangular drape, trapazoidal drape,etc. Indeed, and in normal practice, the lower portion of the drapemerely hangs freely as is shown in FIG. 6.

Further, the bottom portion of the drape can be modified to include aninner pouch for receiving any fecal extrusion during the operationwithout departing from these-ope of the invention, though this is notnecessary.

The invention is not limited to the specially folded structure as thedrape may also be provided in roll form with or without a paper liner.

Since the drape is utilized in surgical operations, each drape ispreferably separately packaged under sterile conditions to provide animmediately usable product, though it is not essential that the productbe supplied in a sterile condition, since its primary use is in childbirth where the portion of the patient covered by the drape of theinvention is not subjected to surgery.

The invention is defined in the claims which follow.

We claim:

1. A bifurcated obstetrical drape comprising a sheet of flexible plasticmaterial having its upper end configurated to define a central arcuatecut-out portion separating a pair of upwardly extending upper endportions, the said cut-out portion being defined by a curved bottomsmoothly joined with outwardly flaring sides defining the inner edges ofsaid upper end portions, said upper end portions being adapted foradhesive securement to the thighs of a patient adjacent the buttockswith the arcuate bottom of said cutout portion being adapted to beadhesively secured across the space between the vaginal area and theanal area of the patient, and one surface of said drape beingtemporarily secured to a stiff sheet.

2. A drape as recited in claim 1 in which said sheet of paper issubstantially coextensive with said drape and the combination of drapeand paper sheet is folded with the paper on the inside, the foldextending across the drape along a line parallel with the upper marginof the drape and positioned a short distance below the bottom of thecut-out portion.

3. A drape as recited in claim 1 in which the bottom of said cut-outportion is curved to correspond with the arc of a circle having a radiusof from /2 inch to 1 inch.

4. A drape as recited in claim 1 in which said stiff sheet istemporarily secured to said one surface of said drape with a pressuresensitive adhesive.

5. A drape as recited in claim 4 in which said cut-out portion has adepth of from 1 /2 inches to 4 inches, and a width which generallycorresponds with its depth.

6. A generally rectangular folded bifurcated obstetrical drapecomprising a sheet of limp flexible plastic material having its upperend configurated to define a central arcuate cut-out portion separatinga pair of upwardly extending upper end portions, the said cut-outportion being defined by a curved bottom smoothly joined with outwardlyflaring sides defining the inner edges of said upper end portions, thebottom of said cut-out portion being curved to correspond with the arcof a circle having a radius of from /2 inch to 1 inch, and said cut-outportion having a depth of from 1 /2 inches to 4 inches, and a Widthwhich generally corresponds With said depth; and a still? paper linersubstantially coextensive with said drape, said liner being removablysecured to one surface of said drape; the said drape with its paperliner being folded with the paper on the inside, the fold extendingacross the drape along a line parallel with the upper margin of thedrape and poistioned a short distance below the bottom of said cut-outportion.

7. A drape as recited in claim 6 in Which the surface of said paperliner facing said drape is thinly coated with Wax and said Wax coatedpaper liner is lightly heat sealed to said drape.

8. A drape as recited in claim 6 in which the bottom of said cut-outportion is curved to correspond With the arc of a circle having a radiusof about inch, and said 6 cut-out portion has a depth of about 2%inches, and a shape which corresponds generally to about /a of anellipse Which has been bisected across its smaller diameter. 9. Thedrape structure defined in claim 8 treated to render it sterile andindividually packaged in said sterile condition.

References Cited by the Examiner UNITED STATES PATENTS 2,056,998 10/1936 Beiter 250 2,593,121 4/1952 Djorup 2--114 2,647,510 8/1953Topmiller 128156 3,060,932 10/1962 Pereny et a1. 128-132 3,090,6945/1963 Pereny et al. 106-477 ADELE M. EAGER, Primary Examiner.

1. A BIFURCATED OBSTETRICAL DRAPE COMPRISING A SHEET OF FLEXIBLE PLASTICMATERIAL HAVING ITS UPPER END CONFIGURATED TO DEFINE A CENTRAL ARCUATECUT-OUT PORTION SEPARATING A PAIR OF UPWARDLY EXTENDING UPPER ENDPORTIONS, THE SAID CUT-OUT PORTION BEING DEFINED BY A CURVED BOTTOMSMOOTHLY JOINED WITH OUTWARDLY FLARING SIDES DEFINING THE INNER EDGES OFSAID UPPER END PORTIONS, SAID UPPER END PORTIONS BEING ADAPTED FORADHESIVE SECUREMENT TO THE THIGHS OF A PATIENT